12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYCOPLASMA IGM ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
SYSTEM, TOMOGRAPHY, COMPUTED EMISSION
FDA 510(k)
FDA Class 2
·Radiology
SYNCHRON® ALT REAGENT, 2 X 200 TEST
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CKA·July 26, 2011
COMPLETE SE ILIAC
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIO·February 21, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 31, 2014
GENESIS II
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., GERMANY MANUFACTURING SITE·Product code JWH·January 27, 2011
AIA-900
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·February 24, 2016
TOSOH AIA-900
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·December 13, 2016
A1A-600II
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·October 28, 2016
TOSOH AIA-1800
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·November 11, 2016
AIA-360
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·March 3, 2016